A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants W… (NCT05361174) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
United States53 participantsStarted 2022-07-20
Plain-language summary
This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
✓. Participants who have received the following previous therapy:
✓. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
✓. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:
✓. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Participants who is assessed as having at least one resectable lesion.
✓. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
✓. Participants who have adequate organ function.
Exclusion criteria
✕. Participants who have melanoma of uveal/ocular origin.
✕. Participants who have symptomatic untreated brain metastases.
✕. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
✕. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
What they're measuring
1
Phase I: Safety of IOV-4001
Timeframe: Up to 1 Year or depending on when the recommended phase 2 dose is determined